RES Committee London - Hampstead Annual Report 01 April 2014 … · RES Committee London - Hampstead Annual Report Page 3 Chair’s overview of the past year: This year was my third

Research Ethics Service

RES Committee London - Hampstead

Annual Report

01 April 2014 - 31 March 2015

RES Committee London - Hampstead Annual Report Page 2

Part 1 – Committee Membership and Training

Name of REC: RES Committee London - Hampstead Type of REC: Recognised, Type I and Type III Type of Flag: Phase 1 studies in healthy volunteers, Paediatric Chair: Miss Stephanie Ellis Vice-Chair: Dr Manish Saxena Alternate Vice-Chair: Mr Paul Hardiman REC Manager: Mr Atul Patel April 2014 – June 2014

Miss Shehnaz Ishaq and Miss Anna Bannister June 2014 – October 2014 Dr Ashley Totenhofer October 2014 - Date

REC Assistant: Miss Regina Caden September 2014 – January 2015

Miss Amber Ecclestone January 2015 – Date Committee Address: Barlow House

3rd Floor 4 Minshull Street Manchester M1 3DZ

Telephone: 0161 625 7815 Email: [email protected]

mailto:[email protected]


Chair’s overview of the past year:

This year was my third year as Chair of Hampstead REC. I am grateful to everyone on the committee for their commitment and helpfulness. Dr Ashley Totenhofer has joined us as our manager and he supports very well. We strive to be a friendly helpful committee. We recognise that one of the most worrying parts of doing medical research is facing a Research Ethics Committee, especially attending a meeting. It can be a very daunting experience. I am pleased how many researchers come back to us. They will probably never get to the stage of enjoying being reviewed by a REC, but they seem to recognise that we are fair and helpful in our comments. We continue to have the problem of students who come to us having received little or no support from their supervisors. This is the eighth year I have had to report continuing dissatisfaction with the poor support some researchers receive from their supervisors. We have had a number of researchers whose applications have been given scant scrutiny by anyone and as a result their proposals have not shown their efforts in the best light. Preferable to issuing Unfavourable opinions, we prefer to provide the researcher with feedback that helps them change their proposal to one that no longer raises ethical issues. A number of times we have had to write directly to the supervisor to remind them of their responsibilities to their students and get them to provide a more appropriate level of supervision. Having said that the quality of most of the research is good: very good indeed - well thought out and presented. The changes we most often ask for are ones more to with the information provided to potential participants: and mainly to make it more likely they will agree to take part. Our Committee continues to work well. I never cease to be impressed by the commitment of the members. They put in a lot of work, not only during the meeting but before hand when they read everything very carefully. Those researchers who attend our meetings see us for only a short time, but they rapidly realise that we have looked at their applications very carefully and can help them improve them still further. We were sorry to see Sarah Wisniewski go.


RES Committee London - Hampstead Membership

RES Committee London - Hampstead: Deputy Members

RES Committee London - Hampstead: Co-opted Members

Name Profession Expert or Lay

Dates

Appointed Left

Dr Waheeb Atia Retired Consultant Physician

Expert 01/11/2010

Mrs Jacqueline Birks Senior Medical Statistician

Expert 12/10/2008

Dr Rahul Chodhari Consultant Paediatrician Expert 03/04/2008

Miss Stephanie Ellis Former Civil Servant Lay Plus 21/01/2013

Dr Alicia Isabel Etchegoyen

Psychiatrist Expert 12/11/2013

Mr Paul Hardiman Consultant Gynaecologist/Senior Lecturer in Obstetrics and Gynaecology

Expert 01/09/2010

Dr Michael Jacobs Retired Academic Pharmacologist

Lay 14/05/2013

Miss Monica Jefford Retired Midwife Lay 31/08/2011

Miss Mina Karamshi Specialist Sister in Radiology

Expert 02/11/2010

Dr Jane Lees-Millais General Practitioner Expert 01/07/2011

Ms Anna Osadcow Clinical Trials Research Pharmacist

Expert 01/01/2013

Ms Ann Rosenthal Literary Consultant (Retired)

Lay Plus 01/01/2014

Dr Manish Saxena Clinical Lecturer and Clinical Research Fellow

Expert 01/07/2013

Mrs Arlene Renee Seaton Retired Medical Publisher Lay Plus 06/02/2013

Mrs Wendy Spicer Pharmacist Expert 01/12/2005

Dr Latha Padma Weston Consultant Psychiatrist Expert 14/12/2011

Miss Sarah Louisa Wisniewski

General Manager for Emergency Services

Lay Plus 18/05/2011 14/01/2015

Name Profession Status Meeting date attended

Dr Victoria Chapman Consultant Child and Adolescent Psychiatrist

Expert 09/04/2014, 10/09/2014, 11/06/2014, 08/10/2014, 12/11/2014, 14/01/2015,

11/03/2015

Name Profession Status Meeting date attended

Dr Alan Ruben GP (Retired) Expert 16th April 2014 PR Sub-Committee


RES Committee London - Hampstead: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Waheeb Atia Member of BMA 31/12/2014

Mrs Jacqueline Birks Peer Reviews for NIHR 11/03/2015

Dr Victoria Chapman Member of BMA 31/12/2014

Dr Rahul Chodhari Provides general practice teaching on regular basis to improve paediatric care. There is no research element involved

Received Pharma support for unrestricted educational grant to attend paediatric allergy meeting

13/02/2015

Miss Stephanie Ellis None 31/12/2014

Dr Alicia Isabel Etchegoyen None 14/01/2015

Dr Michael Jacobs None 31/12/2014

Miss Monica Jefford Shares in British Telecom, Iberdrola, SSE plc

St Andrew's Church, Coulsdon member, Croydon Churches Floating Shelter Volunteer

Croydon Neighbourhood Care Association, Affiliation with through St Andrew's Church Contact Group

Croydon Neighbourhood Care Association, Affiliation with through St Andrew's Church Contact Group

Croydon Voluntary Action

Bowel Cancer UK volunteer

CRUK Involvement Coach

The Royal Marsden NHS Foundation Trust: i) Bank Administration Post - Biomedical

Research Centre ii) Patient and Carer Research Review Panel

Member iii) Patient and Carer Advisory Group Member iv) Clinical Research Facility Member

Institute of Cancer Research: Trial Management Group Member

NCRI/N Member

SE London Consumer Research Panel Member

NIHR Clinical Research Network - South London Member

Faculty of Health and Social Care Sciences, Kingston University, St George's University of London

PPI sessions with radiography students

Guy's and St Thomas' NHS Foundation Trust: Chaplain - Bank Post

Peer Review at various hospitals

31/12/2014

Miss Mina Karamshi None 10/03/2015


Dr Jane Lees-Millais None 14/01/2015

Ms Anna Osadcow Advise on pharmaceutical issues to academic sponsor (UCL) on request for CTIMP studies

31/12/2014

Ms Ann Rosenthal None 31/12/2014

Dr Manish Saxena Chair NRES Committee London - Brent

Member BHS

PI and Co-investigator on many academic and commercial studies at Barts Health

11/03/2015

Mrs Arlene Renee Seaton None 14/01/2015

Mrs Wendy Spicer None 14/01/2015

Dr Latha Padma Weston Trustee at Barnet Bereavement Society 31/12/2014

Mr Paul Hardiman Clinical Academic at UCL - Supervising clinical and laboratory projects

31/03/2015


Meetings for Full Ethical Review 01 April 2014 - 31 March 2015:

Proportionate Review Sub-Committee Meetings held during 01 April 2014 - 31 March 2015:

Sub-Committee Meetings held during 01 April 2014 - 31 March 2015:

Month Date Number of Members Present at Meeting

April 09/04/2014 15

June 11/06/2014 14

September 10/09/2014 11

October 08/10/2014 13

November 12/11/2014 12

December 10/12/2014 9

January 14/01/2015 10

February 11/02/2015 13

March 11/03/2015 14

9 full committee meetings were held during the reporting period.


April 16/04/2014 3

June 09/06/2014 3

July 09/07/2014 3

August 13/08/2014 3

September 08/09/2014 3

October 13/10/2014 3

November 18/11/2014 3

December 22/12/2014 3

January 21/01/2015 3

February 12/02/2015 3

March 17/03/2015 3

11 proportionate review sub-committee meetings were held during the reporting period.


April 07/04/2014 2

May 07/05/2014 2

June 02/06/2014 2

June 19/06/2014 2

July 07/07/2014 2

July 21/07/2014 2

July 22/07/2014 2

August 21/08/2014 2

August 22/08/2014 2





Details of inquorate meeting held: 01 April 2014 - 31 March 2015

October 10/10/2014 2

October 22/10/2014 5

October 31/10/2014 3

November 06/11/2014 2

November 18/11/2014 2

December 02/12/2014 2

December 18/12/2014 2

January 12/01/2015 2

February 03/02/2015 2

February 12/02/2015 2

February 24/02/2015 2

March 11/03/2015 2

24 sub-committee meetings were held during the reporting period. No inquorate meetings held.


Attendance of Members at full committee meetings: 01 April 2014 - 31 March 2015

Attendance of Members at proportionate review sub-committee meetings: 01 April 2014 - 31 March 2015

Name Number of Meetings Attended

Dr Waheeb Atia 9

Mrs Jacqueline Birks 4

Dr Victoria Chapman 7

Dr Rahul Chodhari 2

Miss Stephanie Ellis 9

Dr Alicia Isabel Etchegoyen 5

Mr Paul Hardiman 6

Dr Michael Jacobs 7

Miss Monica Jefford 8

Miss Mina Karamshi 6

Dr Jane Lees-Millais 4

Ms Anna Osadcow 7

Ms Ann Rosenthal 7

Dr Manish Saxena 6

Mrs Arlene Renee Seaton 9

Mrs Wendy Spicer 7

Dr Latha Padma Weston 6

Miss Sarah Louisa Wisniewski 2


Dr Waheeb Atia 1

Dr Rahul Chodhari 1



Mr Paul Hardiman 2

Dr Michael Jacobs 1




Ms Anna Osadcow 1

Ms Ann Rosenthal 1

Dr Manish Saxena 2


Mrs Wendy Spicer 1

Dr Latha Padma Weston 1



Attendance of Members at sub-committee meetings: 01 April 2014 - 31 March 2015


Dr Waheeb Atia 2

Dr Victoria Chapman 3

Dr Rahul Chodhari 3



Dr Michael Jacobs 2




Ms Ann Rosenthal 1

Dr Manish Saxena 3


Mrs Wendy Spicer 1



Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Dr Waheeb Atia 06/01/2015 MRC Workshop - Regulatory Support centre

Dr Michael Jacobs 30/04/2014 CTIMP e-learning Course

Dr Michael Jacobs 07/08/2014 Read 'Testing Treatment: better Research for Better Health'

Dr Michael Jacobs 10/11/2014 Handling Health Related Findings in Research

Dr Jane Lees-Millais 01/02/2015 Mental Capacity Act

Miss Stephanie Ellis 05/09/2014 Oxford REC Local Training Day

Miss Stephanie Ellis 25/09/2014 Presentation on applying to RECs

Miss Stephanie Ellis 19/11/2014 Lecture of applying to RECs

Miss Stephanie Ellis 07/03/2015 Local Training Day - MCA for Bromley REC


PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIOD

Table 1: Applications assigned to a full committee meeting held within the reporting period:

Table 2: Breakdown of full applications and other activity during reporting period

Table 3: Decisions given at meetings held within the reporting period

Applications for full ethical review – Study Type Number %

Clinical Trial of Investigational Medicinal Product 18 40.00

Phase 1 2 4.44

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 0 0.00

Research Database (including renewals) 0 0.00

Others 25 55.56

Total Applications Reviewed 45 100

Number of applications made invalid by the REC Manager 5

Number of applications withdrawn prior to the meeting 0

Number of student applications reviewed 10

Number of paediatric applications reviewed 13

Number of device applications reviewed 2

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 0

Number of applications reviewed that are funded by the US DHHS 0

Number of qualitative applications reviewed 2

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 3 6.67

Favourable Opinion with Additional Conditions 9 20.00

Unfavourable Opinion 0 0.00

Provisional Opinion 33 73.33

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 45 100

Number of studies sent back to full committee meeting for final opinion

0


Table 4: Summary of current status of applications reviewed during the reporting period

Status of applications at date of generation of report Number %

Further Information Favourable Opinion with Standard Conditions

30 66.67

Further Information Favourable Opinion with Additional Conditions

2 4.44

Further Information Unfavourable Opinion 0 0.00





Provisional Opinion Pending Consultation with Referee 0 0.00

Further Information response not complete 0 0.00

No decision entered on system 0 0.00

Number of studies withdrawn after the meeting 1 2.22

Total 45 100


Table 5: Applications assigned to a proportionate review sub-committee within the reporting

period

Table 7: Decisions given at proportionate review sub-committee meetings held within the reporting period

Table 6: Breakdown of PRS applications and other activity during reporting period:

Number of applications made invalid by the REC Manager 6

Number of studies withdrawn prior to the meeting 1

Number of student applications reviewed 12

Number of paediatric applications reviewed 7

Number of device applications reviewed 0

Number of qualitative applications reviewed 4

Total Applications Reviewed 30

Decisions taken at proportionate review sub-committee meetings

Number %



No Opinion transfer to full committee for review 0 0.00



Total 30 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 5.00

Number of applications for full ethical review 44

Number of applications for full ethical review over 60 days 0

Number of applications over 60 days as a % of total 0.00%

Number of applications for full ethical review over 40 days 2

Number of applications over 40 days as a % of total 4.44%

Number of days taken to final decision – average (mean) 22

Number of proportionate review applications for ethical review

30

Number of proportionate review applications for ethical review over 14 days

2

Number of proportionate review applications over 14 days as a % of total

6.67%

Number of SSAs (non-Phase 1) reviewed 2

Number of applications for SSA review over 25 days 0

Number of applications for SSA review over 25 days as % of all non- Phase 1 SSAs

0.00%

Number of SSAs (Phase 1) reviewed 1

Number of applications for SSA review over 14 days 0

Number of applications for SSA review over 14 days as % of all Phase 1 SSAs

0.00%

Number of substantial amendments reviewed 105

Number of substantial amendments over 35 days 7

Number of substantial amendments over 35 days as a % of total substantial amendments

6.67%

Number of substantial amendments over 28 days 15

Number of substantial amendments over 28 days as a % of total substantial amendments

14.29%

Number of modified amendments reviewed 0

Number of modified amendments over 14 days 0

Number of modified amendments over 14 days as a % of total modified amendments

0.00%

Number of minor amendments received 83

Number of substantial amendments received for information 0

Number of substantial amendments received for new sites/PIs

25

Number of annual progress reports received 62

Number of safety reports received 36

Number of Serious Adverse Events received 0

Number of final reports received 18

RES Committee London - Hampstead Research Ethics Committee Annual Report Page 16


REC Reference Title Number of Days on Clock

14/LO/0521 Switching to, then stopping treatment with nilotinib for CML patients. 42

14/LO/0547 Visual & multisensory processing in patients with sight loss. 31

14/LO/0568 Screening for depression in South Asians with End Stage Renal Disease 25

14/LO/0831 Quantitative test of the resynchronization hypothesis for CRT 19

14/LO/0883 Reducing the Impact of Childhood Hypoglycaemia Evaluation Study v1 57

14/LO/0892 Phase 1 study of MEDI4736 in Myelodysplastic Syndrome 22

14/LO/1027 Optimisation of FDG activity in PET imaging 31

14/LO/1454 The Scleroderma Patient Centered Intervention Network (SPIN) Cohort 20

14/LO/1459 Study of MMXÂ® Mesalamine/Mesalazine in Paediatric Ulcerative Colitis 21

14/LO/1536 261202: BAX855 in children with severe haemophilia A 36

14/LO/1738 Safety, Tolerability, PK and PD of ASP3700 as MAD in healthy subjects 19

14/LO/1739 PRESIDE (9785-MA-1001) 22

14/LO/2014 Phase 3 ALN-TTRSC in Familial Amyloidotic Cardiomyopathy 20

14/LO/2035 Alnylam - ALN-TTR02-004 - TTR Mediated Polyneuropathy (FAP) 19

14/LO/2037 Riociguat in diffuse cutaneous systemic sclerosis (dcSSc) 20

14/LO/2166 A multimodal investigation of treatment enhancers for eating disorders 16

14/LO/2179 071101: rVWF in Subjects with Severe VWD Undergoing Surgery 22

14/LO/2182 TheraSphere in Unresectable Hepatocellular Carcinoma (HCC) TS-103 26

14/LO/2200 Safety and efficacy of C1 esterase inhibitor in prophylactic treatment 18

15/LO/0050 Preschool wheeze: Inflammation/Infection Guided Management (PrIGMa) v1 12

15/LO/0054 Microbiota in Crohn’s disease 25

15/LO/0065 Laparoscopic placement of prosthetic anal sphincter 16

15/LO/0073 Sclero XIII 17

15/LO/0075 Phase 3 study in treatment-naÃ¯ve HIV-1 infected subjects 20

15/LO/0208 Prevalence of TTR Mutations in Cardiac Amyloidosis 22

15/LO/0273 Randomised, Phase 3 study for subjects with Early Stage TNBC 18

15/LO/0277 High flow oxygen with THRIVE results in better oxygenation 18

15/LO/0282 I1F-MC-RHBE Ixekizumab in patients with active psoriatic arthritis 19

15/LO/0424 PK of Efavirenz & Lopinavir Nano-Formulations in Healthy Volunteers 24

15/LO/0464 The EQUIP Trial 22




14/LO/1582 MD PAEDIGREE Cardiomyopathies 26

14/LO/1802 Exjade new formulation study (Eclipse) 23

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/LO/1409 Acute Respiratory Tract Illness in an HIV infected population 20

14/LO/2191 Patient perspectives after a shoulder fracture 16

15/LO/0051 FI intervention study (FINS) 16

Favourable Opinion with Additional Conditions


14/LO/0868 Millennium Cohort Study 20

14/LO/1548 HRQL and Health Behaviours in Paediatric SCD Populations (Version 1) 20

14/LO/1817 Lower limb specific training in patients with COPD 17

14/LO/1881 Prospective cohort study - AURAH 2 20

14/LO/1970 Coping with Unusual ExperienceS for 12-18 year olds (CUES+) 19

14/LO/2033 PROVENT: Version 1.0 20

15/LO/0278 Harvoni in Adolescents and Children with HCV 18

15/LO/0441 Study of Melatonin for treatment of Nocturia in PD 20

15/LO/0467 The longitudinal effects of endotoxemia in haemodialysis patients 21

Unfavourable Opinion


Provisional Opinion



Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period

Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting


14/LO/0558 Txt4heart mobile phone based intervention RCT 18



14/LO/1677 KOLCOV HF Study 6

15/LO/0478 Longitudinal trajectories in brain function in infancy 11

15/LO/0483 Prevalence of Acute and Chronic Kidney Disease in the ICU (PEACE) 11



Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/LO/1088 Molecular Pathology of Glaucoma 5


14/LO/1089 REMinD Research on Electronic MedIcatioN Devices 7

14/LO/1231 DVT and its effect on clot microstructure 8

14/LO/1281 Social Anxiety Following Traumatic Brain Injury 7

14/LO/1507 Patients,parents and professionals opinions on childhood hypermobility 10

14/LO/1510 Systemic inflammation in DLB and AD 12

14/LO/1537 NARNIA Study - Version 1.0 11

14/LO/1823 Biomarker validation studies in UKCTOCS breast cancer samples 14

14/LO/2076 Brain changes after cochlear implantation 4

14/LO/2086 Immune damage and repair after vascular injury 8

15/LO/0116 Development of 3D tissue engineered bone-oral mucosa composite model 15

15/LO/0321 Regulation of innate lymphoid cells 7

15/LO/0475 Serum Growth Factors in Sleep Disordered Breathing 10

15/LO/0479 Role of T Follicular cells in the pathogenesis of CVID 7

Favourable Opinion with Additional Conditions


14/LO/0689 Understanding how design can mobilise knowledge into practice V1 15

14/LO/1232 A randomised controlled trial of GSV radiofrequency ablation devices 9

14/LO/1506 Lack of CRP response in patients with active rheumatoid arthritis 12

14/LO/1671 Evaluation of Fetal Ultrasound Telemedicine Service 8

14/LO/1816 Incidence and characterisation of sight loss in giant cell arteritis 14

14/LO/1819 Assessment of tissue oxygen consumption with NIRS VOT and O2K - V 1.2 14

14/LO/1822 Let's Get Moving augmented with a social action intervention 14

14/LO/2075 COMMUNITY MUSIC AND WELLBEING v.1 8

14/LO/2294 Quality of Life and Obesity 12

15/LO/0310 Stomach-specific biomarkers in histological staging of gastritis 7

15/LO/0313 The reliability and validity of the WAIS-IV in ID V1 6

15/LO/0315 Physical Activity Questionnaire for CKD 7

Unfavourable Opinion


14/LO/1674 Influence of the reflecting team on the family meaning system 5


Provisional Opinion


Further information response not complete


Withdrawn after the meeting



Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period

Favourable opinion

Amendment REC Reference

Title Version Date Number of Days on Clock

04/Q0501/119/AM04

The Investigation of the cause and the mechanism of Immunodeficiency di

Substantial Amendment 4

27/02/2015 8

07/Q0501/48/AM69 RADICALS (MRC PR10) 5 27/03/2014 17

09/H0720/132/AM16 Phase 3 study of Lenalidomide in castrate-resitant prostate cancer

13 22/05/2014 23

09/H0720/133/AM18 MDS patients treated with deferasirox for transfusional iron overload

CICL670A2302, version 5

22/09/2014 4

09/H0720/135/AM12 EFC10891 (HMR1726D - Teriflunomide) - Version 1.0, 27-Nov-2008

21/03/2014 36

09/H0720/23/AM12 A Phase 3 Study of Nilotinib versus Imatinib in GIST Patients 7 16/12/2013 25

10/H0720/55/AM05 Study of transmission risk between HIV discordant partners Substantial Amendment 2,

26/5/

19/05/2014 19

10/H0720/60/AM13 REMICADE treatment in the prevention of Crohn's disease recurrence

04/06/2014 26

10/H0720/60/AM14 REMICADE treatment in the prevention of Crohn's disease recurrence

Investigator's Brochure

17/12/2014 3

10/H0720/80/AM03 The UCH Preterm Development Project v1 Amendment 3 28/07/2014 17

10/H0720/87/AM02 Image guidance for laparoscopic liver evaluation 1 05/06/2014 19

11/LO/0023/AM08 Coping with unusual experiences for children study (CUES) Amendment 4 27/12/2014 20

11/LO/0077/AM06 Cognitive Impairment in People with HIV in the European Region(CIPHER)

Amendment 4 23/07/2014 7

11/LO/0190/AM08 JVBA - Docetaxel and Ramucirumab for treating lung cancer 13/05/2014 35

11/LO/0425/AM11 SYCAMORE Substantial Amendment v10.0,

6

19/05/2014 20

11/LO/0608/AM14 Phase 2 study of MDV3100 for metastatic prostate cancer 9785-CL-0222 Protocol

Amendment

28/07/2014 12

11/LO/0608/AM15 Phase 2 study of MDV3100 for metastatic prostate cancer Investigator's Brochure Edition

02/01/2015 6

11/LO/1658/AM11 Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric


24/06/2014 25


11/LO/1805/AM04 A phase 1 study of AEB071 in patients with metastatic uveal melanoma

COEB071X2102 amendment #2

date

08/07/2014 6

11/LO/2036/AM11 Phase I/II Safety, PK & Efficacy Study of Oral Rucaparib Investigator Brochure V5 19 Se

27/10/2014 8

12/LO/0025/AM13 NN7088-3859 Trial Evaluating Safety and Efficacy of N8-GP in Haem A

07 12/08/2014 13

12/LO/0026/AM08 NN7088-3860 Efficacy and Safety of N8-GP during Surgery in Haem A

5 12/08/2014 13

12/LO/0078/AM03 The effects of Early Palliative Care in Mesothelioma SA3 30/04/2014 48

12/LO/0078/AM04 The effects of Early Palliative Care in Mesothelioma AM04 23/02/2015 14

12/LO/0219/AM04 A pedometer intervention to increase walking in adults: PACE-UP trial

3 25/09/2014 7

12/LO/0261/AM05 HARMONY trial 23/04/2014 22

12/LO/0486/AM12 Safety, PK/PD study in adult patients with severe Haemophilia A or B

15/04/2014 35

12/LO/0803/AM09 AZD5363 in patients with advanced or metastatic breast cancer (BEECH)

13/05/2014 14


D360C0002, CSP Amendment 3 - P

13/05/2014 20


D3610C00002 - PIS V5

09/12/2014 9


D3610C00002 Amendment to PIS

V

12/02/2015 12

12/LO/0977/AM05 Investigation of a novel intervention in Acute HIV Infection (AHI)

3 07/02/2014 37

12/LO/1173/AM04 Study to see if GSK2110183 with chemotherapy can treat ovarian cancer

16/04/2014 33


Investigator Brochure Update

08/09/2014 8


Change In Chief Investigator

20/02/2015 15

12/LO/1411/AM01 NeSST2: The development of a non-invasive Short Synacthen Test

Amendment 1 23/06/2014 14

12/LO/1418/AM09 GIFTS Amendment N 5 15/10/2014 12

12/LO/1422/AM02 LuDo SA01 First 03/09/2014 7


Protocol Amendment

12/LO/1759/AM07 OuTSMART 7 07/04/2014 42

12/LO/1759/AM08 OuTSMART Protocol version 8 01/07/2014 12

12/LO/1759/AM09 OuTSMART Protocol Version 9 (Amendment

15/10/2014 7

13/LO/0016/AM01 Baxter 281101: Phase 1 Study of Safety and Pharmacokinetics in TTP

1 05/08/2014 7

13/LO/0016/AM02 Baxter 281101: Phase 1 Study of Safety and Pharmacokinetics in TTP


26/01/2015 15

13/LO/0032/AM03 Genetic and environmental risk factors for Acanthamoeba keratitis

4 28/08/2014 6

13/LO/0120/AM09 LDE225 versus temozolomide in patients with medulloblastoma

Amendment #2 17/04/2014 28

13/LO/0246/AM03 Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH)

Amendment Number 3

12/05/2014 25

13/LO/0316/AM02 Web-based support for self-management of diabetes 2 01/04/2014 23

13/LO/0335/AM01 CMV gB vaccine long term antibody response. Version 1.0 13November2012


17/09/2014 7

13/LO/0482/AM04 Reducing the frequency and severity of voices: AVATAR Clinical Trial

09/04/2014 41


Amendment 5 20/06/2014 22


Amendment 6 19/01/2015 21

13/LO/0634/AM01 Late onset depression: Correlates of dopaminergic function Substantial Amendment 1

25/07/2014 12

13/LO/0634/AM02 Late onset depression: Correlates of dopaminergic function 1 25/07/2014 3

13/LO/0815/AM05 Long Term Antibiotic Therapy on Exacerbation frequency in Stable COPD

4 10/02/2014 35


5 17/09/2014 13


Amendment 6 Protocol Version 5

11/09/2014 14

13/LO/0847/AM02 IPF-PRoM Study 23

13/LO/1085/AM01 The London Alpha-1-Antitrypsin Deficiency Cohort 1 08/04/2014 28


13/LO/1104/AM02 PB-102-F02: Extension of the PB-102-F01 study (PRX-102 for ERT in Fabr

Protocol Version 4A UK only &I

19/02/2015 4

13/LO/1184/AM03 TheraSphereÂ® vs soc Sorafenib in Hepatocellular Carcinoma with PVT

TS104 YES-P Protocol Version 3

08/08/2014 10

13/LO/1321/AM04 GB28547 - Lebrikizumab in patients with idiopathic pulmonary fibrosis

2 13/05/2014 34

13/LO/1321/AM05 GB28547 - Lebrikizumab in patients with idiopathic pulmonary fibrosis


29/07/2014 23

13/LO/1323/AM02 A study of Ferriprox to see how safe it is and how well it works 16/04/2014 27

13/LO/1323/AM03 A study of Ferriprox to see how safe it is and how well it works Protocol Amendment 7

12/08/2014 3

13/LO/1323/AM04 A study of Ferriprox to see how safe it is and how well it works Investigator Brochure

20/01/2015 7

13/LO/1335/AM01 OM-85-BV Mechanistic study in COPD 03/04/2014 41

13/LO/1335/AM02 OM-85-BV Mechanistic study in COPD BV2013/5 20/10/2014 4

13/LO/1335/AM03 OM-85-BV Mechanistic study in COPD BV2013/5 20/01/2015 5

13/LO/1453/AM01 Exhaled hydrogen sulphide in asthma 2 24/06/2014 27

13/LO/1453/AM02 Exhaled hydrogen sulphide in asthma Substantial Amendment 3

17/02/2015 6

13/LO/1509/AM02 An investigation of the microorganisms present in diabetic foot ulcers

2 16/09/2014 14

13/LO/1509/AM03 An investigation of the microorganisms present in diabetic foot ulcers

Amendment 03 18/02/2015 4

13/LO/1514/AM02 Improved testing for microsatellite instability in tumour tissue Protocol 10th September 2013,

19/02/2015 13

13/LO/1520/AM02 Study Of Diabetic Nephropathy with Atrasentan 02 15/04/2014 34

13/LO/1520/AM04 Study Of Diabetic Nephropathy with Atrasentan Sub Amd 03 18/09/2014 12

13/LO/1655/AM01 Effects of ageing on connective tissue metabolism in female prolapse

24/04/2014 26

13/LO/1700/AM01 VX09-809-102 Lumacaftor Alone and Lumacaftor/Ivacaftor in Adult CF

VX09-809-102 protocol

amendment

02/05/2014 31

13/LO/1707/AM01 Investigating the pathophysiology of mesenteric infarction 1 05/09/2014 13

13/LO/1725/AM01 Randomised comparison of iFR to FFR 4.1 12/02/2014 34

13/LO/1968/AM01 Developing the concept of 'being a carer' for use in cancer care v1

1 20/05/2014 13


13/LO/1968/AM02 Developing the concept of 'being a carer' for use in cancer care v1

2 01/09/2014 18

14/LO/0120/AM01 Zibotentan better renal scleroderma outcome study (ZEBRA) 20/03/2014 40

14/LO/0121/AM03 PAKT 2 23/04/2014 21

14/LO/0129/AM01 Respiratory and peripheral muscle function in people with lung cancer

PIS Amendment 1 27/11/2014 9

14/LO/0521/AM01 Switching to, then stopping treatment with nilotinib for CML patients.

1.0 01/04/2014 9

14/LO/0547/AM01 Visual & multisensory processing in patients with sight loss. Amendment Number 1

29/07/2014 17

14/LO/0547/AM02 Visual & multisensory processing in patients with sight loss. Amendment Number 2

18/12/2014 16

14/LO/0568/AM01 Screening for depression in South Asians with End Stage Renal Disease

Amendment Number 1

22/09/2014 10

14/LO/0892/AM01 Phase 1 study of MEDI4736 in Myelodysplastic Syndrome Substantial Amendment (Protocol)

10/07/2014 13

14/LO/0892/AM03 Phase 1 study of MEDI4736 in Myelodysplastic Syndrome Updated Main Study PIS-ICF V2.

19/12/2014 24

14/LO/1231/AM01 DVT and its effect on clot microstructure Amendment 1 12/08/2014 22

14/LO/1281/AM01 Social Anxiety Following Traumatic Brain Injury One 15/07/2014 8

14/LO/1281/AM02 Social Anxiety Following Traumatic Brain Injury Substantial Amendment 2

24/07/2014 23

14/LO/1459/AM01 Study of MMXÂ® Mesalamine/Mesalazine in Paediatric Ulcerative Colitis

Amendment 1 20/11/2014 11

14/LO/1536/AM02 261202: BAX855 in children with severe haemophilia A UK EC SA#2 Inconvenience

Payment

24/11/2014 8

14/LO/1536/AM03 261202: BAX855 in children with severe haemophilia A UK EC SA#3 - Protocol

Amendment

17/12/2014 26

14/LO/1536/AM04 261202: BAX855 in children with severe haemophilia A UK EC SA#4 - eDiary Quick Refe

22/12/2014 21

14/LO/1739/AM01 PRESIDE (9785-MA-1001) APL Amendment A - change PIS f

01/12/2014 17

14/LO/1739/AM02 PRESIDE (9785-MA-1001) APL Amendment B - Substantial

27/10/2014 26


Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period

14/LO/1739/AM04 PRESIDE (9785-MA-1001) APL Amendment C - change PIS f

19/01/2015 22

14/LO/1739/AM08 PRESIDE (9785-MA-1001) APL Amendment F- updated IB

26/01/2015 4

14/LO/1802/AM01 Exjade new formulation study (Eclipse) Amendment 1 09/02/2015 12

14/LO/1816/AM02 Incidence and characterisation of sight loss in giant cell arteritis Substantial Amendment 1

04/12/2014 25

14/LO/1816/AM04 Incidence and characterisation of sight loss in giant cell arteritis Substantial Amendment 2

18/02/2015 15

14/LO/2179/AM01 071101: rVWF in Subjects with Severe VWD Undergoing Surgery

UK EC Substantial Amendment #1

06/03/2015 4

Unfavourable opinion



Favourable opinion timeline



Unfavourable opinion timeline




Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timeline


Proportionate review applications for ethical review over 14 day timeline


14/LO/0689 Understanding how design can mobilise knowledge into practice V1 15

15/LO/0116 Development of 3D tissue engineered bone-oral mucosa composite model 15

SSAs (non Phase 1) over 25 day timeline


SSAs (Phase 1) over 14 day timeline


Substantial Amendments over 35 day timeline



09/H0720/135/AM12 EFC10891 (HMR1726D - Teriflunomide) - Version 1.0, 27-Nov-2008

21/03/2014 36

12/LO/0078/AM03 The effects of Early Palliative Care in Mesothelioma SA3 30/04/2014 48

12/LO/0977/AM05 Investigation of a novel intervention in Acute HIV Infection 3 07/02/2014 37

12/LO/1759/AM07 OuTSMART 7 07/04/2014 42


09/04/2014 41

13/LO/1335/AM01 OM-85-BV Mechanistic study in COPD 03/04/2014 41

14/LO/0120/AM01 Zibotentan better renal scleroderma outcome study (ZEBRA) 20/03/2014 40

Modified Amendments over 14 day timeline



Documents

RES Committee London - Hampstead Annual Report 01 April 2014 … · RES Committee London - Hampstead Annual Report Page 3 Chair’s overview of the past year: This year was my third